Table 1 Work-Packages (WP) of the PREPARE Study: role, goals and participating countries

WP1

Project Management, Scientific Coordination and Oversight of Capacity Building.

To ensure conduct of all research activities to the highest standards, including oversight and coordination of the other WPs to ensure deliverables and milestones are met.

United Kingdom

South Africa

WP2

Clinical trial site development and GBS disease surveillance.

To establish the GBS disease incidence in an urban Ugandan cohort followed to 3 months of age and establish the baseline rates of common obstetric and neonatal outcomes in preparation for WP4 and WP5.

Uganda

South Africa

United Kingdom

WP3

Developing serocorrelates of protection against GBS

To develop a biobank of prospectively collected sera from cases of GBS disease and associated GBS disease isolates from a network of African and European sites in order to define serocorrelates of protection against GBS, using standardized antibody assays.

Uganda,

Malawi,

South Africa,

United Kingdom,

Italy,

France,

Netherlands

WP4

Multivalent CPS-conjugate vaccine trial.

To conduct a phase II study of a multivalent vaccine against the GBS CPS in pregnant HIV-infected and uninfected women and to establish a platform for future trials with new GBS vaccines.

United Kingdom

Uganda

WP5

Minervax Alp-NN GBS vaccine trial.

To conduct a phase II study of a multivalent vaccine against the Alp and Rib proteins on the surface of GBS in pregnant HIV-infected and uninfected women and to establish a platform for future trials with new GBS vaccines.

Denmark

United Kingdom

South Africa

WP6

Communications, networking and dissemination.

To develop a strategy for patient and public involvement, communications, capacity strengthening and stakeholder engagement.

United Kingdom